MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number PCF-HQ190L

Device Problems Mechanical Problem (1384); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

The customer reported to olympus, that the colonovideoscope was glitching and received an e315 incompatible scope error code.The issue was found during an unspecified diagnostic procedure.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information, device evaluation, and the legal manufacturer's investigation results.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.The device was returned to olympus for inspection, and the reported event was confirmed.Based on the results of the investigation, water invaded the device and most likely led to the reported failure and an abnormal image.However, the root cause of the water invasion could not be specified.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: "chapter 3 preparation and inspection the equipment prepared before using this endoscope and procedures for inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning ¿ using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage." "chapter 5 troubleshooting the countermeasures against troubles are described in this chapter.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Warning ¿ never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18361385
• MDR Text Key: 330956749
• Report Number: 9610595-2023-19932
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170416118
• UDI-Public: 04953170416118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1